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Leflunomide

Generic name: leflunomide [le-FLOO-noe-mide]
Arava
Oral tablet (10 mg or 20 mg)
Drug classes: antirheumatics, selective immunosuppressants

What is Leflunomide?

Leflunomide reduces inflammation and swelling in the body and affects the immune system.Leflunomide treats the symptoms of rheumatoid arthritis.Leflunomide can be used in other ways not mentioned in this guide.

Side effects of Leflunomide

If you experience any of the following symptoms of an allergic reaction, seek immediate medical attention: hives, difficulty breathing, swelling of the face, lips, or throat.

Leflunomide may cause serious side effects. If you experience:

  • Signs of infection: sudden weakness; fever; chills; sore Mouth sores. Red or swollen gingivae
  • Feeling short of breath, chest discomfort or pain, or a dry cough
  • Easy bruising or bleeding; purple or red pinpoints under the skin, nose, mouth, vagina, or rectum;
  • You may experience tingling or burning in your feet or hands.
  • Liver problems: nausea; upper stomach pains; itching; fatigue; loss of appetite; and dark urine.
  • Severe skin reaction—fever and sore throat. Swelling of the face and tongue. Burning in your eyes. Then a reddish or purple rash spreads to other parts of your body, especially your face and upper part.

Leflunomide can cause the following side effects:

  • Symptoms of nausea include diarrhoea and stomach pain.
  • Headache;
  • Abnormal liver function tests
  • Hair loss is a common problem.
  • Backache
  • Weakness;
  • Rash;
  • High blood pressure.

There may be other side effects. For medical advice on side effects, call your doctor. Contacting the FDA directly in regards to adverse side effects is possible by dialling 1-800-FDA-1088.

Similar/related drugs

Simponi, Olumiant, hydroxychloroquine, Humira, Enbrel, Remicade, and Rituxan

Warnings

Stop taking leflunomide immediately if you are pregnant. Use birth control during the time you take leflunomide and until you have completed a "drug-elimination" procedure.Leflunomide may cause serious or even fatal liver damage.You will need to test your liver function frequently, and you might need to stop using leflunomide depending on the results.

Before you take this drug

This medicine should not be used if you have an allergy to leflunomide, teriflunomide, or any of the following:

  • You are pregnant (you must have a negative pregnancy result before you begin this treatment);
  • You have severe liver disease.
  • You are also taking teriflunomide.

Do not use leflunomide while pregnant or if you may become pregnant. Wait to get pregnant until you have stopped taking leflunomide. If you are pregnant or miss your period, stop taking leflunomide immediately and contact your doctor.

Tell your doctor about any of the following to ensure that leflunomide will not harm you:

  • A history of liver disease (leflunomide may cause serious liver problems);
  • A severe or uncontrolled illness;
  • Kidney disease
  • Nervous disorders, such as neuropathy due to diabetes,
  • A history of tuberculosis
  • A weak immune system, or a bone marrow disease;
  • If you use any medications that can weaken your immunity (such as cancer medicines or steroids),

Prevent pregnancy by using birth control while taking this medication. Continue to use birth control after you stop taking leflunomide until you receive blood tests that confirm the drug is no longer in your body.Ask your doctor whether you should use a barrier birth control method (condom, diaphragm, or spermicide). Leflunomide may cause liver damage if you use hormonal contraception.Leflunomide is not known to pass into breast milk. It is also unknown if the drug could harm a baby who was nursing. This medicine should not be taken while breastfeeding.

How to take leflunomide?

Your doctor will likely perform tests before you begin treatment to ensure that you are not infected with tuberculosis.Please follow all the instructions on the prescription label. Your doctor may change your dosage from time to time. Leflunomide should not be used in higher or lower doses or for longer than prescribed.You will need to check your blood pressure often.Leflunomide lowers blood cells, which help the body fight infections and clot blood. You will have to test your blood frequently. These tests may cause your leflunomide to be temporarily stopped.You will need to test your liver function frequently, and if the results are negative, you may have to stop taking leflunomide.You may need to take other medications to help your body get rid of leflunomide as quickly as possible after you stop taking it. Leflunomide can stay in your system for up to two years if you don't undergo this drug-elimination procedure. Please follow your doctor's advice.This drug elimination process is also required if you intend to get pregnant after stopping leflunomide.Combinations of medications are often used to treat arthritis. Follow your doctor's instructions when taking all medications. Each medication comes with a patient instruction guide or medication guide. You should not alter your medication or doses without consulting your doctor.Store away from moisture, heat, and light at room temperature.

Details on dosage

Adult dose for rheumatoid arthritis:

Loading dosage: 100 mg once daily for three days
Maintenance: 20mg orally, once daily (if not well tolerated, the dose can be reduced to 10mg orally, once daily).
Comment:
Monitoring of liver enzymes and haematology parameters is recommended.
Use:
Treatment of active rheumatoid (RA) arthritis:
Reduce symptoms
Prevent structural damage, as shown by X-ray erosions or joint space narrowing.
To improve physical function

What happens if I miss the dose?

As soon as you recall, take the missed dose. If your next scheduled dosage is approaching, skip the missed dose. You should not take more medicine to compensate for a missed dose.

What happens if I overdose?

Call 1-800-222-1222 for poison help or seek immediate medical attention.Overdose symptoms include diarrhoea, nausea, abdominal pain, pale or bluish skin, easy bleeding or bruising, dark urine, or jaundice.

What should be avoided?

Avoid people with colds, flu, or other contagious diseases. If you notice any signs of infection, contact your doctor immediately.You could get a serious infection if you receive a live vaccine while taking leflunomide. Live vaccines are available for measles (chickenpox), rubella (MMR), yellow fever, typhoid (rotavirus), varicella, zoster, and influenza (nasal flu).

Interaction with other drug

Leflunomide may cause liver damage that is severe or fatal. The severity of this effect increases if you use other drugs, such as:

  • Nsaids (non-steroidal, anti-inflammatory drugs): ibuprofen, naproxen, celecoxib (Advil), diclofenac (Indomethacin), meloxicam, and others.
  • An antibiotic, antifungal medicine, or sulfa drug; tuberculosis medicine; antiviral or HIV/AIDS medication; medicine to treat mental illness; seizure medication—carbamazepine, phenytoin, valproic acid, and others;
  • Birth control pills or hormone replacement therapy; anabolic steroids (methyltestosterone, "performance-enhancing drugs"); cancer medication;
  • Heart or blood pressure medications; cholesterol-lowering medications—Zycor, Lipitor, and others

Leflunomide can interact with many drugs not listed here. Included are prescription and over-the-counter medicines, vitamins, and herbal products. You should give a complete list of your medications to any healthcare professional who treats you. This medication guide does not cover every potential interaction.

 

DRUG STATUS

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Prescription only

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